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12. Organisational, regulatory and methodological matters
12.1. Mandate and organisation of the PRAC
12.1.1. PRAC Work Programme
Draft PRAC Work Programme 2014-2015
The PRAC discussed further development of the PRAC work plan and topic leaders. Further discussion
to identify deliverables for 2015 will take place at the July 2014 meeting of the PRAC.
12.2. Pharmacovigilance audits and inspections
None
12.3. Periodic Safety Update Reports & Union Reference Date (EURD) List
12.3.1. Union Reference Date List
Consultation on the draft list, version June 2014
On CMDh’s request, PRAC advice was sought on whether the DLP for piracetam could have been
brought forward. Piracetam is a substance contained in nationally authorised products and included in
the EURD list as a single substance and in combination with other active substances. During the
assessment of renewals for piracetam-containing medicinal products, two Member States requested
the deletion of one indication - due to lack of efficacy - and these cases have been brought to the
attention of the CMDh according to the provisions of Article 107i, paragraph 1 of Directive 2001/83/EC.
The PRAC advised that in order to address this issue other regulatory procedures should be explored
first. Therefore it was not considered appropriate to amend the EURD list at this point in time.
The PRAC endorsed the draft revised EURD list version June 2014 reflecting the PRAC comments
impacting DLP and PSUR submission frequencies of the substances/combinations.
The EMA secretariat also presented a proposal to set up a group ((granularity and periodicity advisory
group (GPAG)) composed of NCA representatives from CMDh and PRAC as well as EMA to review and
rationalise the EURD list. The PRAC delegates were invited to express their interests in participating in
this group by 7 July 2014.
Post-meeting note: following the PRAC meeting in June 2014, the updated EURD list was adopted by
the CHMP at its June 2014 meeting and published on the EMA website on 02/07/2014 (see:
Home>Regulatory>Human medicines>Pharmacovigilance>EU reference date and PSUR submission).
12.4. Signal Management
12.4.1. Signal Management
Feedback from Signal Management Review Technical (SMART) Working Group
The SMART Working Group discussed various topics including the updated signal assessment template
and improvement in the format and details of the PRAC recommendations for signals as transmitted to
MAHs.
At the organisational matters teleconference held on 26 June 2014, the EMA secretariat presented
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 45/75